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Functional Magnetic Resonance Imaging (MRI) of Hypnosis and Mindfulness Meditation

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ClinicalTrials.gov Identifier: NCT01135810
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
David Spiegel, Stanford University

Tracking Information
First Submitted Date June 1, 2010
First Posted Date June 3, 2010
Last Update Posted Date December 3, 2013
Study Start Date September 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2010)
MRI scan: brain activity [ Time Frame: 1 hour ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01135810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Magnetic Resonance Imaging (MRI) of Hypnosis and Mindfulness Meditation
Official Title Resting State Functional MRI Investigation of Hypnotic Trance and Mindfulness Meditation
Brief Summary Hypnotic trance and mindfulness meditation have both been shown to have benefits for physical health. The current study seeks to determine if there are distinct patterns of brain activity that correlate with hypnotic trance, mindfulness meditation or both, and to relate these patterns to measurable markers of physical well-being. Precise neuroimaging of heightened attentional states will guide future researchers and practitioners toward more effective techniques of mind/body control.
Detailed Description

Our goal is to determine the functional brain networks that define and distinguish two induced states of sustained attention -- hypnosis and mindfulness -- that may be of substantial relevance to medicine.

Defining the neural underpinnings of these states would have broad implications for understanding how cognitive states emerge from functional networks, how they affect peripheral autonomic nervous system activity, and how their therapeutic efficacy can be optimized.

We propose a functional MRI study using resting state methodology to study 20-40 subjects from each of the four following groups:

  1. Highly hypnotizable subjects
  2. Minimally hypnotizable subjects
  3. Experienced mindfulness meditators
  4. Novice mindfulness meditators. The ability to be hypnotized is a stable and measurable trait that can be pre-screened and quantified. Dr. Spiegel will select subjects according to their ability to be hypnotized prior to the MRI visit (see ?recruiting? below). We will seek greatest contrast between groups by enrolling those with the highest (8-10) and lowest (0-2) scores on the Hypnotic Induction Profile. The presence of a poorly hypnotizable group allows for a control condition of those who have undergone an identical induction routine without achieving hypnotic trance. Similarly, novice meditators will serve as a control for the group experienced in mindfulness meditation.

Prior studies have shown differences in both brain activation and grey matter volume associated with longer practice of meditation (> 4 years) compared with novice meditators. As such, experienced meditators will be defined as those with a regular meditation practice of four years or longer. Novice meditators will be new practitioners who are interested in mindfulness meditation practice, and who completed a one-hour meditation training during the week before their study participation.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood
Sampling Method Non-Probability Sample
Study Population Healthy subjects who score in diverse ranges on hypnotic induction profiles or who are experienced Mindfulness Meditators.
Condition Hypnosis
Intervention
  • Behavioral: Hypnosis
  • Behavioral: Meditation
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2013)
102
Original Estimated Enrollment
 (submitted: June 2, 2010)
80
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants must not have contraindications to the MRI exam, such as metal in the body.

Exclusion Criteria:

  • Contraindications to the MRI exam, such as metal in the body.
  • Use of psychotropic medications.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01135810
Other Study ID Numbers SU-05252010-6143
17562
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David Spiegel, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: David Spiegel Stanford University
PRS Account Stanford University
Verification Date December 2013